Regulatory Medical Writing Bundle

Regulatory and medical writing is an integral part of the product development and approval process. It is a skill that must be honed and refined as you gain regulatory knowledge and experience. Learn more about the components of various application types and techniques for improving document quality.

Select which bundle option is right for you:

  • Complete Package
  • Package #1
  • Package #2
  • Package #3
  • Package #4

Complete Package

Products included in this bundle:

Online Course: Introductory Medical Writing
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Importance of Medical Writing from a Regulatory Perspective
  • Lesson 2: Crafting an Effective Message
  • Lesson 3: Basic Statistics
  • Lesson 4: Improving Document Quality

3–6 Hours | 3 RAC Credits

Online Course: Intermediate Medical Writing: Investigational Applications
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Investigational New Drug Application (IND)
  • Lesson 2: Investigational Device Exemptions (IDE)
  • Lesson 3: Canadian Clinical Trial Application
  • Lesson 4: Investigational Testing Authorization (ITA)
  • Lesson 5: Investigational Medicinal Product Dossier (IMPD)
  • Lesson 6: European Clinical Trial Application

6–12 Hours | 6 RAC Credits

Online Course: Intermediate Medical Writing: Medical Devices
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Premarket Approval (PMA)
  • Lesson 2: 510(k) Premarket Notification

2–4 Hours | 2 RAC Credits

Online Course: Intermediate Medical Writing: Pharmaceuticals and Biologics
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Common Technical Document (CTD)
  • Lesson 2: New Drugs Application (NDA)
  • Lesson 3: Biological License Application (BLA)
  • Lesson 4: Marketing Authorisation Application (MAA)

3–6 Hours | 3 RAC Credits

Register for this Bundle

Package #1

Products included in this bundle:

Online Course: Introductory Medical Writing
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Importance of Medical Writing from a Regulatory Perspective
  • Lesson 2: Crafting an Effective Message
  • Lesson 3: Basic Statistics
  • Lesson 4: Improving Document Quality

3–6 Hours | 3 RAC Points

Online Course: Intermediate Medical Writing: Investigational Applications
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Investigational New Drug Application (IND)
  • Lesson 2: Investigational Device Exemptions (IDE)
  • Lesson 3: Canadian Clinical Trial Application
  • Lesson 4: Investigational Testing Authorization (ITA)
  • Lesson 5: Investigational Medicinal Product Dossier (IMPD)
  • Lesson 6: European Clinical Trial Application

6–12 Hours | 6 RAC Points

Online Course: Intermediate Medical Writing: Pharmaceuticals and Biologics
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Common Technical Document (CTD)
  • Lesson 2: New Drugs Application (NDA)
  • Lesson 3: Biological License Application (BLA)
  • Lesson 4: Marketing Authorisation Application (MAA)

3–6 Hours | 3 RAC Points

Register for this Bundle

Package #2

Products included in this bundle:

Online Course: Introductory Medical Writing
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Importance of Medical Writing from a Regulatory Perspective
  • Lesson 2: Crafting an Effective Message
  • Lesson 3: Basic Statistics
  • Lesson 4: Improving Document Quality

3–6 Hours | 3 RAC Points

Online Course: Intermediate Medical Writing: Investigational Applications
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Investigational New Drug Application (IND)
  • Lesson 2: Investigational Device Exemptions (IDE)
  • Lesson 3: Canadian Clinical Trial Application
  • Lesson 4: Investigational Testing Authorization (ITA)
  • Lesson 5: Investigational Medicinal Product Dossier (IMPD)
  • Lesson 6: European Clinical Trial Application

6–12 Hours | 6 RAC Points

Online Course: Intermediate Medical Writing: Medical Devices
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Premarket Approval (PMA)
  • Lesson 2: 510(k) Premarket Notification

2–4 Hours | 2 RAC Points

Register for this Bundle

Package #3

Products included in this bundle:

Online Course: Intermediate Medical Writing: Investigational Applications
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Investigational New Drug Application (IND)
  • Lesson 2: Investigational Device Exemptions (IDE)
  • Lesson 3: Canadian Clinical Trial Application
  • Lesson 4: Investigational Testing Authorization (ITA)
  • Lesson 5: Investigational Medicinal Product Dossier (IMPD)
  • Lesson 6: European Clinical Trial Application

6–12 Hours | 6 RAC Points

Online Course: Intermediate Medical Writing: Medical Devices
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Premarket Approval (PMA)
  • Lesson 2: 510(k) Premarket Notification

2–3 Hours | 2 RAC Points

Online Course: Intermediate Medical Writing: Pharmaceuticals and Biologics
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Common Technical Document (CTD)
  • Lesson 2: New Drugs Application (NDA)
  • Lesson 3: Biological License Application (BLA)
  • Lesson 4: Marketing Authorisation Application (MAA)

3–6 Hours | 3 RAC Points

Register for this Bundle

Package #4

Products included in this bundle:

Online Course: Introductory Medical Writing
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Importance of Medical Writing from a Regulatory Perspective
  • Lesson 2: Crafting an Effective Message
  • Lesson 3: Basic Statistics
  • Lesson 4: Improving Document Quality

3–6 Hours | 3 RAC Points

Online Course: Intermediate Medical Writing: Medical Devices
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Premarket Approval (PMA)
  • Lesson 2: 510(k) Premarket Notification

2–4 Hours | 2 RAC Points

Online Course: Intermediate Medical Writing: Pharmaceuticals and Biologics
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Common Technical Document (CTD)
  • Lesson 2: New Drugs Application (NDA)
  • Lesson 3: Biological License Application (BLA)
  • Lesson 4: Marketing Authorisation Application (MAA)

3–6 Hours | 3 RAC Points

Register for this Bundle